NCT00834717

Granisetron 1 mg Tablets Under Fasting Conditions

A Single-Dose, Comparative Bioavailability Study of Two Formulations of Granisetron 1 mg Tablets Under Fasting Conditions

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Teva Pharmaceuticals USA · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The objective of this study is to evaluate the comparative bioavailability between granisetron hydrochloride 1 mg tablets (Teva Pharmaceuticals USA) and Kytril® 1 mg tablets (Roche, USA), after a single-dose in health subjects under fasting conditions.

Detailed description

Criteria for Evaluation: FDA Bioequivalence Criteria Statistical Methods: FDA bioequivalence statistical methods

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Granisetron hydrochloride 1 mg tablets	2 x 1 mg, single dose fasting
DRUG	Kytril® 1 mg tablets	2 x 1 mg, single dose fasting

Timeline

• Start date: 2005-09-01
• Primary completion: 2005-09-01
• Completion: 2005-09-01
• First posted: 2009-02-03
• Last updated: 2024-08-19
• Results posted: 2009-08-04

Locations

1 site across 1 country: Canada